The invention relates to systems and methods for recording data during the course of fluid processing procedures, such as those carried out by blood processing systems and the like.
Today people routinely separate whole blood by centrifugation into its various therapeutic components, such as red blood cells, platelets, and plasma.
These and other medical processing devices are often controlled using microprocessors with resident program software. The microprocessors also usually include some type of interface through which the operator views and comprehends information regarding the operation of the fluid processing systems.
These and other medical processing devices also often require the ability to record key control and processing parameters during the course of a procedure, as well as to keep track of operator intervention during the procedure. These data recording functions are useful, as they support, e.g., GMP requirements, instrument trouble shooting and problem diagnosis, and instrument performance evaluation. Still, while important, data recording functions should not compete or interfere with the overall processing tasks and objectives of the procedure.
As the operational and performance demands upon such fluid processing systems become more complex and sophisticated, the need exists for integrating, automating, and fortifying data recording functions.
The invention provides systems and methods, which fully integrate data recording functions with processing functions. Thus, the same instrument that carries out the processing tasks also performs the data recording functions, without the need for add-on, external data recording systems.
The invention also provides systems and methods, which fully automate necessary data recording functions, so that they can be accomplished xe2x80x9cin the background,xe2x80x9d without significant operator intervention or control.
The invention also provides robust systems and methods, which carry out data recording functions that withstand real world abuse, such as power failure or corruption of stored data. This xe2x80x9ccrash-proofxe2x80x9d aspect is particularly significant in an embedded software systems environment, where an instrument may be powered off at any time.
One aspect of the invention provides systems and methods for processing data during a blood processing procedure. The systems and methods monitor status conditions over time during the blood processing procedure and generate data based upon monitored status conditions. The systems and methods write the data to a flash memory storage medium. In a preferred embodiment, the systems and methods retrieve and manipulate the data written to the flash memory storage medium.
The use of flash memory provides reliability and compact size, so that robust data storage, retrieval, and processing functions can be carried out on-board a blood processing device, without need for external computing devices and without concern about the durability and reliability of the data storage functions.
According to another aspect of the invention, blood processing systems and methods employ a device that has processing hardware to carry out a blood processing procedure. A processing control manager resides on the device to monitor status conditions over time during the blood processing procedure. A data interface also resides on the device. The data interface includes a data storage medium formatted to allocate discrete block file spaces to receive data.
In a preferred embodiment, chronologic data or time-specific data can be created, based upon sensed conditions by a file generator task, which resides on the device. A file manager task operates to append chronologic data in an allocated file space to create a chronologic block file. When read, the chronologic block file provides a time-ordered account of processing activities or hardware conditions. The file management element also operates to block-write time-specific data to another allocated file space. When read, each time-specific data file provides a snap-shot of processing conditions at a given point in time. The data file structure created withstands corruption of data due to power failure.
The features and advantages of the invention will become apparent from the following description, the drawings, and the claims.